Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating women who have advanced or metastatic breast cancer that has not responded to previous chemotherapy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Oxaliplatin Single Agent in Patients With Metastatic Breast Cancer After Failure of Anthracycline/Taxane Based Chemotherapy|
|Study Start Date:||May 2000|
|Primary Completion Date:||May 2002 (Final data collection date for primary outcome measure)|
- Determine the therapeutic activity of oxaliplatin in patients with advanced or metastatic breast cancer following failure of anthracycline/taxane based chemotherapy.
- Determine objective response, duration of response, and time to progression in these patients when treated with this regimen.
- Determine the acute side effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 weeks until disease progression and then every 3 months for survival.
PROJECTED ACCRUAL: A total of 27-40 patients will be accrued for this study.
|Kaiser Franz Josef Hospital|
|Vienna (Wien), Austria, A-1100|
|Institut Jules Bordet|
|Brussels (Bruxelles), Belgium, 1000|
|CHU de la Timone|
|Marseille, France, 13385|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Eugene Marquis|
|Rennes, France, 35064|
|Hamburg, Germany, D-20246|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Schneider Children's Medical Center of Israel|
|Petah-Tikva, Israel, 49202|
|Institute of Oncology, Ljubljana|
|Ljubljana, Slovenia, Sl-1000|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Pierre Fumoleau, MD, PhD||Centre de Lutte Contre le Cancer Georges-Francois Leclerc|